Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

National Cancer Institute (NCI)

Funding Opportunity Title

Cardiovascular and Pulmonary Research on E-Cigarettes (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-HL-17-021

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-18-024

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.838, 93.837, 93.396

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to stimulate research on cardiovascular and pulmonary physiologic and health effects of electronic cigarette (e-cigarette) exposure. This FOA invites applications addressing the effects of e-cigarettes on the cardiovascular and pulmonary systems, alone or in combination. Studies involving clinical populations, animal models and/or cell preparations would all be considered responsive.  Research may examine the effects of the whole e-cigarette aerosol or of individual components or constituents. Research may also examine where aerosols, components, or constituents deposit in the airways and resulting heart and/or lung consequences.

Key Dates

 

Posted Date

August 1, 2017

Open Date (Earliest Submission Date)

December 16, 2017

Letter of Intent Due Date(s)

December 16, 2017

Application Due Date(s)

January 16, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2018

Advisory Council Review

August 2018

Earliest Start Date

September 2018

Expiration Date

January 17, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Background

Electronic cigarettes, or e-cigarettes, are battery-powered devices that heat and vaporize a liquid mixture (also called e-liquid or e-juice), typically containing a vehicle such as propylene glycol and/or vegetable glycerine and often but not always nicotine and/or flavorings, to produce an aerosol that is inhaled by the user. Research on e-cigarettes has become an area of great importance as e-cigarette popularity has seen high rates of growth in recent years. Rapid increases in use among youth highlight the need for understanding short- as well as long-term effects of e-cigarette aerosol inhalation. In addition, understanding the relative health impact of e-cigarettes compared to conventional cigarettes is particularly relevant information for individuals who plan to use e-cigarettes as a replacement for combusted tobacco products. Although it is well known that traditional cigarette use causes or exacerbates multiple cardiovascular and pulmonary diseases, such as COPD and coronary heart disease, the health implications of e-cigarette use are largely unknown. Based on health effects of other inhalation exposures, likely organs to be affected by e-cigarettes include the heart and lung.  This lack of data on harms or relative safety of e-cigarettes has made it exceptionally difficult for individuals, healthcare providers, regulating bodies, and other organizations to make informed decisions about e-cigarette use, guidance, and policy.

The components, mode of delivery, and use patterns of e-cigarettes are different from those of traditional cigarettes, and their cardiopulmonary effects also may be different.  First, while there is evidence that carbon-based particles resulting from cigarette combustion are harmful to the heart and lung if inhaled, very little is known about effects of inhalation of the liquid-based particles e-cigarettes generate or even where they deposit in the lung. In addition, while the many flavoring chemicals used in e-cigarette liquids have been approved for human ingestion, the health effects of inhalation of heated components are unclear and potentially significant. For example, diacetyl, the flavoring component used in butter-flavored microwave popcorn and which is present in many e-liquids, is harmless if ingested but can cause a serious condition called obliterative bronchiolitis or “popcorn lung” if inhaled in significant quantities. Furthermore, the e-cigarette heating process itself drives chemical reactions in the e-liquid, so what the user inhales might significantly differ from what was purchased. Known toxins like acrolein and formaldehyde have been identified in e-cigarette aerosols. Finally, other dangers may result from inhalation of components not present in cigarette smoke, such as propylene glycol or metal contaminants. These could result in unexpected physiologic effects, possibly quite different from the effects caused by cigarette smoke. 

Program Scope and Research Objectives

The goal of this FOA is to form a foundational basis of research on the increasingly popular behavior of e-cigarette use, which may have significant health implications. The science of e-cigarettes and their potential health effects is in its infancy. Research will be required at all levels, from mechanistic studies to cohort and clinical investigations. 

This FOA is intended to support research that investigates the physiologic or health effects of e-cigarette exposures on the cardiovascular and pulmonary systems, alone or in combination. Proposed research should be relevant to products and constituents that are commercially available and to the inhalation of these products by individuals who use e-cigarettes. Studies involving clinical populations, animal models, and cell preparations are all permitted. Because nicotine is a constituent of many tobacco products in addition to e-cigarettes, applications solely devoted to investigating effects of nicotine will not be considered. However, nicotine may be one of several constituents or aerosol characteristics tested in a particular application. Research may examine the effects of the whole e-cigarette aerosol or of individual components or constituents. Research may examine where aerosols, components, or constituents deposit in the airways and the resulting heart and/or lung consequences. Research may also examine the heart or lung effects of e-cigarette use on at-risk populations such as those with pre-existing heart or lung disease.

This FOA is intended to support research teams comprised of investigators from multiple disciplines. Depending on research aims, investigator expertise may represent diverse fields such as aerosol sciences, inhalation toxicology, engineering, chemistry, and cardiopulmonary biology. Annual meetings of grantees will be held in Bethesda, MD which will allow investigators to share experience, methods, reagents, and data. 

National Heart, Lung, and Blood Institute (NHLBI)

Examples of research that could be supported by this FOA include, but are not limited to, the following:

  • Effect of inhalation of liquid particles, oxidation products of e-liquid constituents, or metal particle contaminants on mechanisms of cardiopulmonary function and pathogenesis of cardiopulmonary disease;
  • Cardiopulmonary effects of chronic exposure to e-cigarette aerosols;
  • Comparison between effects of e-cigarette aerosols and cigarette smoke on mechanisms of heart or lung disease;
  • Effect of inhalation of e-cigarette flavoring compounds and other additives on the lung innate immune system and the pathogenesis of lung diseases;
  • Cardiovascular toxicity of e-cigarette use in older individuals with heart disease;
  • Effects of e-cigarette use on severity and symptoms of pre-existing lung disease;
  • Lung deposition pattern of e-cigarette aerosols and components, and its effects on lung function;
  • Studies investigating how e-liquid chemistry influences particle size, lung deposition, and respiratory outcomes;
  • Effect of activation of airway taste receptors by e-cigarette aerosols on lung function and disease;
  • Effects of e-cigarette aerosol exposure in pregnant women on the fetus during cardiopulmonary development;
  • Effects of e-cigarette aerosol inhalation on cardiopulmonary function in youth and young adults;
  • Studies comparing the cardiopulmonary effects of individual components of e-cigarettes in isolation with their effects as part of an integrated composite mixture;
  • Investigations of e-cigarette exposure on cardiac myocytes, endothelial cells, platelets and inflammatory cells that contribute to atherosclerotic lesions;
  • Prospective cohort studies of cardiovascular effects of e-cigarette use on subclinical markers of cardiopulmonary disease progression and risk factors, including ancillary studies to existing cohorts;
  • Cardiopulmonary effects of second-hand exposure to e-cigarette emissions.

National Cancer Institute (NCI)

The NCI encourages submission of applications to understand the roles and mechanisms of e-cigarette exposure in lung cancer biology.  Applications should focus on constituents or aerosols unique to e-cigarettes; studies examining e-cigarette components that have been well-studied in other tobacco products or other health contexts are discouraged. Examples of specific topics of interest to the NCI include but are not limited to:

  • Effects of e-cigarette aerosols on lung carcinogenesis, tumor progression, metastasis and the tumor microenvironment;
  • Effects of e-cigarette exposure on the response or resistance to targeted, radiation, or chemo therapies used for lung cancer;
  • Consequences of e-cigarette aerosol exposure in animal models relevant to human lung cancer;
  • Cellular and molecular mechanisms of lung carcinogenicity by exposure to e-cigarette aerosols;
  • Identification and validation of specific molecular markers of e-cigarette exposure or carcinogenicity in the lung.

Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed:

  • Effect of only nicotine on the cardiovascular or pulmonary systems, not specific to e-cigarette use;
  • Prevalence of e-cigarette use, if cardiovascular and/or pulmonary physiologic/health effects are not also examined;
  • Studies on the components of e-cigarette aerosols that do not also investigate their lung deposition, cardiovascular, and/or pulmonary physiologic/health effects;
  • Effects of e-cigarette use on behaviors such as cigarette smoking and addiction. 

NHLBI policies regarding relevant clinical research/studies policies are described in the NHLBI Policy for Inclusion of Women and Minorities in Clinical Research and the NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHLBI intends to commit total costs of $1,920,000 in FY 2017, $3,840,000 in FY 2018 through FY2020, and $1,920,000 in FY 2021.

NHLBI intends to fund up to 4 new awards in FY2017 and up to 4 new awards in FY2018.

NCI intends to commit $500,000 total costs in each of FY2018 through FY2021. The NCI intends to fund one award.

Award Budget

Application budgets should reflect the actual needs of the proposed project. Application budgets may not exceed $300,000 direct costs per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 4 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  Multidisciplinary investigator teams are required. Profiles should specify the expertise and experience relevant to the proposed research project for all key personnel.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Budgets should include travel for PD(s)/PI(s) to attend annual one-day meetings of grantees in Bethesda, MD.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Research Strategy: 

Applicants are strongly encouraged to include a discussion of e-cigarette research methodology as appropriate for the proposed Aims. For example, if an application proposes a cohort study, applications should include a discussion of measurements such as survey questions to assess e-cigarette use. If an application proposes animal exposure to e-cigarette aerosols, a description of the exposure methodology, including comparison to expected exposures experienced by e-cigarette users, should be included. If an application proposes experimental use of e-cigarettes, it should include a description of e-cigarette characteristics. These may include, as appropriate: brand, power, temperature, heating element resistance, propylene glycol and vegetable glycerine concentrations, nicotine concentrations, flavorings, other constituents, and puff characteristics.

Applicants should describe how the expertise of the PD(s)/PI(s) will be leveraged to achieve the goals of the specific aims (possibly including such areas as aerosol sciences, inhalation toxicology, engineering, chemistry, and cardiopulmonary biology).

NHLBI plans to arrange annual one-day meetings to review progress and to encourage discussion and exchange of research ideas, methods, and reagents among the investigators. At these meetings, awardees will be expected to share their results and help evaluate progress. Attendance at these meetings is required. Applications should include a statement indicating willingness of the PD(s)/PI(s) to participate in one meeting each year to be held in the Bethesda, Maryland area to encourage and facilitate the exchange of information among participating investigators.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • Resource Sharing Plans should address how data pertaining to the effects of e-cigarettes on the cardiovascular and pulmonary systems will be made publicly accessible in a timely manner.

Applicants should discuss how validated protocols, methodologies, and other resources will be disseminated to the scientific community.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

How does this research relate to products and constituents that are commercially available and to the inhalation of these products by individuals who use e-cigarettes? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

How does the expertise represented by the multidisciplinary team, possibly including such areas as aerosol sciences, inhalation toxicology, engineering, chemistry, and cardiopulmonary biology, assure the ability to investigate physiologic or health effects of e-cigarette use?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

To what extent is the proposed e-cigarette research methodology appropriate for the Aims? If relevant, how likely is it that the proposed e-cigarette use measures will result in the collection of relevant usage data? If relevant, how likely is it that the proposed methods to expose animal models to e-cigarette aerosols will relate to expected exposures experienced by e-cigarette users? If relevant, how likely is it that the described e-cigarette characteristics, including, as appropriate:  brand, power, temperature, heating element resistance, propylene glycol and vegetable glycerine concentrations, nicotine concentrations, flavorings, other constituents, and puff characteristics, will support the proposed Aims? Is the plan for dissemination to the scientific community of validated protocols, methodologies, and other resources appropriate? If appropriate, is an adequate plan for monitoring possible changes in nicotine addiction included? Do applicants address any potential ethical concerns posed by the research regarding addiction potential or by experimental e-cigarette use in vulnerable populations such as those with pre-existing heart or lung disease, or youth?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Reviewers will also comment on whether the plan for dissemination to the public of data resulting from this research is appropriate.  

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council or National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Lisa Postow, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Division of Lung Diseases
Telephone: 301-435-0202 
Email: lisa.postow@nih.gov

Catherine M. Stoney, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Division of Cardiovascular Sciences
Telephone: 301-435-6670
Email: stoneyc@mail.nih.gov

Ron Johnson, Ph.D.
National Cancer Institute (NCI)
Division of Cancer Biology
Telephone: 240-276-6250
Email: rjohnso2@mail.nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:  301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Lynn Rundhaugen  
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-4546
Email: lynn.rundhaugen@nih.gov

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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